U.S. patent application number 14/339159 was filed with the patent office on 2015-01-29 for flexible obturator.
The applicant listed for this patent is Arthrex, Inc.. Invention is credited to James J. Guerra, Allen E. Holowecky, Donald K. Shuler, Derek C. Sullivan.
Application Number | 20150032169 14/339159 |
Document ID | / |
Family ID | 52391118 |
Filed Date | 2015-01-29 |
United States Patent
Application |
20150032169 |
Kind Code |
A1 |
Holowecky; Allen E. ; et
al. |
January 29, 2015 |
FLEXIBLE OBTURATOR
Abstract
A flexible obturator configured to dilate soft tissue without
abrading the adjacent bone surface area. The flexible obturator
consists of at least one flexible strand (for example, flexible
wire, suture or similar malleable flexible material) that is
overmolded with a material that allows the device to bend/flex in
multiple planes. The overmolded material has an increasing taper to
provide graduated dilation through soft tissue.
Inventors: |
Holowecky; Allen E.;
(Naples, FL) ; Sullivan; Derek C.; (Bonita
Springs, FL) ; Shuler; Donald K.; (Naples, FL)
; Guerra; James J.; (Naples, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Arthrex, Inc. |
Naples |
FL |
US |
|
|
Family ID: |
52391118 |
Appl. No.: |
14/339159 |
Filed: |
July 23, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61858520 |
Jul 25, 2013 |
|
|
|
Current U.S.
Class: |
606/328 ;
606/90 |
Current CPC
Class: |
A61F 2/0811 20130101;
A61F 2002/0882 20130101; A61F 2002/0858 20130101; A61B 17/842
20130101; A61F 2002/0888 20130101; A61F 2002/0852 20130101; A61F
2/0805 20130101; A61B 2017/0225 20130101; A61B 17/683 20130101 |
Class at
Publication: |
606/328 ;
606/90 |
International
Class: |
A61B 17/02 20060101
A61B017/02; A61B 17/84 20060101 A61B017/84 |
Claims
1. A surgical flexible obturator for dilating tissue, the obturator
consisting of: at least one flexible strand forming at least one
loop at one end; and an overmolded material surrounding at least a
part of the at least one flexible strand, the overmolded material
being adjacent the at least one loop at one end, the overmolded
material extending along a length of the flexible strand.
2. The surgical obturator of claim 1, wherein the overmolded
material comprises a material that allows the surgical obturator to
bend in multiple planes relative to its longitudinal axis.
3. The surgical obturator of claim 1, wherein the obturator is a
single use disposable instrument.
4. The surgical obturator of claim 1, wherein the at least one
flexible strand is a wire, a suture, a suture tape, a suture chain,
a filament, a yarn or a fibril.
5. The surgical obturator of claim 1, wherein the at least one
flexible strand is formed of a plurality of braided multi-filament
yarns formed of ultrahigh molecular weight polyethylene.
6. The surgical obturator of claim 1, wherein the at least one
flexible strand comprises resorbable or non-resorbable
material.
7. The surgical obturator of claim 1, wherein the overmolded
material is formed of an elastomer, silicon, or combinations of
elastomers and silicon.
8. The surgical obturator of claim 1, wherein ends of the at least
one flexible strand are brought together in a knot and wherein the
overmolded material surrounds the knot.
9. The surgical obturator of claim 1, wherein the overmolded
material has an increasing taper on each end to provide graduated
dilation through the tissue.
10. A method of AC joint repair, comprising the steps of: providing
an internal fixation device comprising a first member with a first
configuration and provided with a plurality of first apertures; a
second member with a second configuration and provided with a
plurality of second apertures; and a flexible coupling between the
first and second members, the flexible coupling being looped
through the plurality of first and second apertures; securing the
first and second members on or adjacent to the clavicle and the
coracoid, respectively; reducing the distance between the clavicle
and the coracoid; passing a flexible strand around the coracoid;
securing the flexible strand to a flexible obturator consisting of
at least one flexible strand forming at least one loop at one end;
and a molded material surrounding at least a part of the at least
one flexible strand, the molded material being adjacent the at
least one loop, the overmolded material extending along a length of
the flexible strand and completely surrounding the length of the
flexible strand; and shuttling the flexible obturator around the
coracoid to dilate soft tissue.
11. The method of claim 10, wherein the step of passing the
flexible strand around the coracoid further comprises passing a
curved guide instrument from medial to lateral around the
coracoid.
12. The method of claim 10, wherein the flexible obturator is a
disposable instrument.
13. The method of claim 10, further comprising the steps of
attaching a graft to the flexible obturator and passing the graft
around the coracoid.
14. The method of claim 10, wherein at least one of the first and
second members is a button.
15. The method of claim 10, wherein at least one of the first and
second members is a round or oblong button.
16. The method of claim 10, wherein at least one of the first and
second members is a button having a dog bone-shaped
configuration.
17. The method of claim 10, wherein the flexible coupling is
FiberWire.RTM. suture.
18. The method of claim 10, wherein the flexible coupling comprises
ultrahigh molecular weight polyethylene.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/858,520, filed Jul. 25, 2013, the disclosure of
which is incorporated by reference in its entirety herein.
FIELD OF THE INVENTION
[0002] The present invention is directed to surgical instruments
and, particularly, to a flexible obturator used in surgical
procedures.
BACKGROUND OF THE INVENTION
[0003] Dilation of tissue (such as bone or soft tissue) facilitates
passing a biologic component (for example, autograft or allograft
tissue) around, through, or across bony anatomical structures. One
of the instruments employed during arthroscopic or minimally
invasive surgery is a cannulated obturator or soft-tissue dilator
that is typically provided with a blunt tip and is positioned over
a guide pin.
[0004] There is a need for a flexible obturator or a soft tissue
dilator that confers the surgeon the ability to target tissue
adjacent any surface of a bony anatomical structure, such as the
coracoid during acromioclavicular (AC) repairs. Also needed is an
instrument that allows a surgeon the ability to dilate soft tissue
to allow easy graft passage around difficult-to-access areas
surrounding bones. The flexible obturator should desirably
bend/flex in multiple planes.
SUMMARY OF THE INVENTION
[0005] The present invention provides a flexible obturator that is
capable of dilating soft tissue without abrading the adjacent bone
surface area. The flexible obturator consists of at least one
flexible strand (for example, flexible wire, suture or similar
malleable flexible material) that is overmolded with a material
that allows the device to bend/flex in multiple planes. The
overmolded material has an increasing taper to provide graduated
dilation through soft tissue.
[0006] An exemplary method of surgery with the flexible obturator
of the present invention comprises inter alia the steps of: (i)
providing a flexible obturator in the vicinity of soft tissue
attached to bone or cartilage; (ii) inserting the flexible
obturator between the soft tissue and the bone/cartilage; and (iii)
shuttling the flexible obturator around the bone/cartilage to
dilate the soft tissue and allow subsequent passage/insertion of a
graft (for example, allograft).
[0007] These and other features and advantages of the invention
will be more apparent from the following detailed description that
is provided in connection with the accompanying drawings and
illustrated exemplary embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 illustrates an exemplary flexible obturator of the
present invention.
[0009] FIGS. 2-6 illustrate subsequent steps of an exemplary
surgical technique with the flexible obturator of FIG. 1.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0010] The present invention provides a flexible obturator that is
capable of dilating soft tissue while maintaining the adjacent bone
surface area intact (i.e., without abrading the adjacent
bone/cartilage). The flexible obturator is a soft tissue dilator
that confers the surgeon the ability to target tissue adjacent any
surface of a bony anatomical structure, such as the coracoid during
acromioclavicular (AC) repairs. The flexible obturator allows a
surgeon the ability to dilate soft tissue to allow easy graft
passage around difficult-to-access areas surrounding bones.
[0011] The flexible obturator consists of a flexible wire, suture
or similar malleable flexible material that is overmolded with a
material that allows the device to bend/flex in multiple planes.
The overmolded material has an increasing taper to provide
graduated dilation through soft tissue. The flexible obturator
bends/flexes in multiple planes to facilitate soft tissue dilation
while protecting the surrounding bone/cartilage.
[0012] Although the flexible obturator of the present invention has
particular application to the AC joint, the flexible obturator may
be employed in any ligament reconstruction and/or tissue
replacement in any kind of joint, and is not limited to the
exemplary-only AC repair.
[0013] Referring now to the drawings, where like elements are
designated by like reference numerals, FIGS. 1-6 illustrate
flexible obturator 100 of the present invention which may be
positioned between soft tissue and bone or cartilage (for example,
the coracoid) at a specific location and following the normal
curvature of the bone, and repairs with such flexible obturator
100.
[0014] The flexible obturator 100 includes at least one flexible
strand 10 such as a flexible wire, suture, tape or similar
malleable flexible material that is overmolded with a material 20
that allows the device to bend/flex in multiple planes. The
overmolded material 20 has an increasing taper to provide graduated
dilation through soft tissue. The flexible obturator 100
bends/flexes in multiple planes to dilate soft tissue while
protecting the surrounding bone. The flexible obturator 100 is a
smooth graduated dialator for soft tissue dilation which does not
reduce any adjacent bone structures.
[0015] Flexible obturator 100 may be a single-use disposable and
sterile instrument. The at least one flexible strand 10 may be a
single strand or may be formed of multiple strands, or may form at
least one loop 11 of flexible material (i.e., one or both ends of
the flexible strand may be looped to form one or more loops 11). As
noted above, the at least one flexible strand 10 may be formed of
any material, suture, tape, chain, filaments, yarns, fibrils,
loops, knotless suture constructs, etc. The at least one flexible
strand 10 may be formed of any fiber, natural or synthetic,
absorbable or resorbable, braided or non-braided. The at least one
flexible strand 10 may be a FiberWire.RTM. suture or multiple
FiberWire.RTM. sutures.
[0016] Molding 20 may be any moldable, flexible material, for
example an elastomeric, tissue-compatible material such as
silicone, or combination of elastomeric or similar materials (with
additional colorants, if desired). Preferably, molding 20 is
provided with a taper on at least one side, preferably on both
sides/ends of the construct. FIG. 1 illustrates gradual tapers 21,
22 (increasing tapers 21, 22) at ends 23, 24 of the molding 20.
Molding 20 extends along a length of the flexible strand, for
example, completely surrounding length "l" of the flexible strand
10. In the embodiment shown in FIG. 1, length "l" represents about
half the total length "L" of device 100.
[0017] In exemplary-only embodiments, the at least one flexible
strand 10 is a single strand that forms two loops 11, each loop 11
being provided at each end (i.e., at end 13 and opposite end 14 of
the device). The two ends of the strand 10 are brought together to
form a knot 10a, for example, which is covered by the molding 20.
In additional embodiments, the flexible strand forms only one loop
11 at one end, the other end of the flexible strand remaining
un-looped (and covered by the molding 20). In additional
embodiments, the flexible strand may form no loop and have a length
covered by the molding 20.
[0018] In yet additional embodiments, the at least one flexible
strand 10 may be in the form of multiple strands of flexible
material forming multiple flexible loops at one end, for example,
two or more loops 11 located at one end, for example, at end 13.
Loops 11, and any additional loops, may be independently-formed
loops that are all connected by common region. The construct 100
may also include splices and splice regions formed by splicing one
end of the flexible strand 10 within itself, to form loops and/or
loop constructs, as desired. In yet additional embodiments, the at
least one flexible strand 10 may be in the form of a single strand
that branches out in multiple loops 11 (for example, a series of
loops 11a, 11b, etc. as independently-formed loops--not shown) of
flexible material. The loops may be all formed of a similar
material (same flexible strand material) or may be formed of
different materials. The loops allow a graft or tissue (for
example, allograft, autograft, artificial tissue, additional suture
or fixation devices, etc.) to be connected to the construct 100,
i.e., to be passed through and looped over the flexible loops.
[0019] Flexible obturator 100 may be employed in any soft tissue
reconstruction, for example, graft (ligament, tendon, etc.)
reconstruction such as AC joint repair, among many others. Flexible
obturator 100 has particular applicability to the AC repair as the
coracoid anatomy requires the surgeon to manipulate the graft from
medial to lateral and then around the coracoid during the AC
repair, step which poses difficulty during the surgical repair.
Current AC repairs employ a guide which is a curved instrument
(shown as instrument 70 in FIG. 2, for example) to go around the
coracoid and allow tissue (for example, biological and
non-biological materials such as a graft, allograft, tendon,
ligament, etc.) to be pulled around the coracoid. When the graft is
pulled, however, the graft gets stuck in the adjacent soft tissue,
impeding the procedure. With the flexible obturator 100 of the
present invention, and as detailed below, the soft tissue around
the coracoid is dilated allowing the graft to be passed easily
around the coracoid.
[0020] The flexible obturator 100 may be employed in conjunction
with various AC reconstruction techniques, for example, the one
detailed and described in US Publication 2012/0150203, filed Dec.
8, 2011, entitled "Acromioclavicular Joint Fixation Using Suture
Button Construct With Dog Bone-Shaped Button," the disclosure of
which is incorporated in its entirety by reference herein.
[0021] If desired, the graft can be attached to flexible obturator
100 and then both steps can be conducted at the same time, i.e.,
dilation of soft tissue and graft passage/insertion can be
conducted simultaneously. The flexible obturator 100 may be also
hooked to a passing instrument (for example, a passing wire) that
has been already passed around the coracoid.
[0022] FIGS. 2-6 illustrate exemplary steps of a method of soft
tissue reconstruction with the flexible obturator 100 of FIG.
1.
[0023] FIG. 2: Perform desired AC reconstruction (for example, by
employing dog bone buttons 88 and a suture loop construct 82
extending between the two buttons, as detailed in US Publication
2012/0150203, to secure clavicle 80 to coracoid 90). Pass an
instrument 70 from medial to lateral around the coracoid 90. An
exemplary curved guide instrument 70 is used in this example.
[0024] FIG. 3: Use the instrument 70 to pass a wire or suture 72
around area 90a of the coracoid 90, i.e., right around the bone
surface of coracoid 90.
[0025] FIG. 4: Secure the wire or suture 72 to the flexible
obturator 100 (by tying a knot 73, for example) and shuttle it
around area 90a of the coracoid 90 to dilate the soft tissue that
is adjacent and/or contacts bone area 90a of coracoid 90. Pulling
the flexible obturator 100 in the direction of arrow A of FIG. 4
allows the soft tissue in area 90a of the coracoid 90 to distance
itself from the coracoid 90 (i.e., to dilate the anatomical soft
tissue). The wire or suture 72 can be secured to the flexible
obturator 100 by tying the two together, folding the suture,
integrating a FiberLink.TM. with the dilator, or splicing the
sutures together.
[0026] FIGS. 5 and 6: Attach the suture limbs 98a, 98b from tissue
99 (for example, allograft 99) to the flexible obturator 100 and
shuttle around the coracoid 90 (i.e., within area 90a of the
coracoid). Graft 99 is secured to clavicle 80 and around coracoid
90 with fixation devices (for example, fixation devices 95) to
obtain final repair 200 of FIG. 6.
[0027] The flexible strand 10 forming construct 100 may be a
high-strength suture, such as an ultrahigh molecular weight
polyethylene (UHMWPE) suture. Alternatively, the high strength
suture may be a FiberWire.RTM. suture, which is disclosed and
claimed in U.S. Pat. No. 6,716,234, the entire disclosure of which
is incorporated herein by reference in its entirety herewith.
FiberWire.RTM. suture is formed of an advanced, high-strength fiber
material, namely ultrahigh molecular weight polyethylene (UHMWPE),
sold under the tradenames Spectra (Honeywell) and Dyneema (DSM),
braided with at least one other fiber, natural or synthetic, to
form lengths of suture material. The preferred FiberWire.RTM.
suture includes a core within a hollow braided construct, the core
being a twisted yarn of UHMWPE.
[0028] The flexible strand 10 of the present invention may also be
formed of a stiff material, or combination of stiff and flexible
materials, depending on the intended application. The strands may
be also coated and/or provided in different colors.
[0029] Although the present invention has been described in
connection with preferred embodiments, many modifications and
variations will become apparent to those skilled in the art. While
preferred embodiments of the invention have been described and
illustrated above, it should be understood that these are exemplary
of the invention and are not to be considered as limiting.
* * * * *